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Trial record 3 of 538 for:    Argentina | Bulgaria

Safety and Efficacy Study to Determine Anti-Asthmatic Effect of Esomeprazole Magnesium; Nexium Reflux Asthma (RELAX)

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ClinicalTrials.gov Identifier: NCT00317044
Recruitment Status : Completed
First Posted : April 24, 2006
Results First Posted : June 9, 2014
Last Update Posted : June 9, 2014
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Asthma
GERD
Interventions Drug: Esomeprazole
Drug: Placebo
Enrollment 961
Recruitment Details  
Pre-assignment Details Four randomized patients were excluded from the ITT analysis due to missing efficacy data (2 patients), no investigational product given (1 patient), and being unblinded by the investigator (1 patient). The patient who received no investigational product was excluded from the safety analysis and is not included in the Baseline Characteristics.
Arm/Group Title Esomeprazole 40 mg Twice Daily Esomeprazole 40 mg Once Daily Placebo
Hide Arm/Group Description Nexium 40 mg given as esomeprazole magnesium trihydrate capsules twice daily Nexium 40 mg given as esomeprazole magnesium trihydrate capsules once daily Placebo
Period Title: Overall Study
Started 320 313 328
Completed 272 273 283
Not Completed 48 40 45
Reason Not Completed
Protocol Violation             28             22             20
Adverse Event             4             7             4
Withdrawal by Subject             10             7             12
Lost to Follow-up             0             2             3
Multiple Reasons             6             2             6
Arm/Group Title Esomeprazole 40 mg Twice Daily Esomeprazole 40 mg Once Daily Placebo Total
Hide Arm/Group Description Nexium 40 mg given as esomeprazole magnesium trihydrate capsules twice daily Nexium 40 mg given as esomeprazole magnesium trihydrate capsules once daily Placebo Total of all reporting groups
Overall Number of Baseline Participants 319 313 328 960
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 319 participants 313 participants 328 participants 960 participants
44.0
(18 to 69)
45.0
(19 to 70)
45.0
(18 to 70)
44.667
(18 to 70)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 319 participants 313 participants 328 participants 960 participants
Female 240.00 240.00 247.00
727
  75.7%
Male 79.00 73.00 81.00
233
  24.3%
1.Primary Outcome
Title Mean Change in Morning Peak Expiratory Flow (mPEF (L/Minute)) From Baseline (Mean of the Last 7 Days in the run-in Period) to Treatment Period (Mean of All Available Data During the Treatment Period).
Hide Description Peak expiratory flow is defined as the maximum speed of expiration as measured with the Mini-Wright® PEF Meter. Participants must have both baseline and follow up measure to be included in analysis. Results presented as a mean of all available data during the treatment period.
Time Frame Baseline to 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Esomeprazole 40 mg Twice Daily Esomeprazole 40 mg Once Daily Placebo
Hide Arm/Group Description:
Nexium 40 mg given as esomeprazole magnesium trihydrate capsules twice daily
Nexium 40 mg given as esomeprazole magnesium trihydrate capsules once daily
Placebo
Overall Number of Participants Analyzed 316 311 327
Least Squares Mean (Standard Error)
Unit of Measure: L/minute
21.1891  (2.8689) 19.1847  (2.8422) 15.6771  (2.8086)
2.Secondary Outcome
Title Changes in Average Value From Baseline to Treatment Period in Evening Peak Expiratory Flow (ePEF (L/Minute))
Hide Description Peak expiratory flow is defined as the maximum speed of expiration as measured with the Mini-Wright® PEF Meter. Participants must have both baseline and follow up measure to be included in analysis. No dispersion measure available.
Time Frame Baseline to 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Esomeprazole 40 mg Twice Daily Esomeprazole 40 mg Once Daily Placebo
Hide Arm/Group Description:
Nexium 40 mg given as esomeprazole magnesium trihydrate capsules twice daily
Nexium 40 mg given as esomeprazole magnesium trihydrate capsules once daily
Placebo
Overall Number of Participants Analyzed 316 311 326
Least Squares Mean (Standard Error)
Unit of Measure: L/minute
21.88  (2.89) 18.37  (2.87) 18.55  (2.83)
3.Secondary Outcome
Title Changes in Average Value From Baseline to Treatment Period in Asthma Symptom Score - Total
Hide Description Participants must have both baseline and flow up measure to be included in analysis. Each morning and evening, the patient will be asked to record his/her asthma symptoms (sx) in the diary. The asthma sx scores during night- and daytime will be assessed by the patient according to the following scoring system: 0 = no asthma sx; 1 = you are aware of your asthma sx but can easily tolerate the sx; 2 = your asthma sx are causing you enough discomfort to cause problems with normal activities (or with sleep); 3 = you are unable to do your normal activities (or sleep) because of your asthma. The total symptom score is the sum of the night- and daytime scores.
Time Frame Baseline to 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Esomeprazole 40 mg Twice Daily Esomeprazole 40 mg Once Daily Placebo
Hide Arm/Group Description:
Nexium 40 mg given as esomeprazole magnesium trihydrate capsules twice daily
Nexium 40 mg given as esomeprazole magnesium trihydrate capsules once daily
Placebo
Overall Number of Participants Analyzed 315 311 326
Least Squares Mean (Standard Error)
Unit of Measure: Scores on a scale
-0.61  (0.05721) -0.47  (0.05652) -0.52  (0.05609)
4.Secondary Outcome
Title Changes in Average Value From Baseline to Treatment Period in Number of Inhalations of Short-acting β2-agonists (SABAs) - Total From Baseline to 6 Months
Hide Description This is the change in the average number of inhalations from baseline to the end of the study (6 months). Participants must have both baseline and follow up measure to be included in analysis. Treatment mean calculated using the entire treatment period.
Time Frame Baseline to 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Esomeprazole 40 mg Twice Daily Esomeprazole 40 mg Once Daily Placebo
Hide Arm/Group Description:
Nexium 40 mg given as esomeprazole magnesium trihydrate capsules twice daily
Nexium 40 mg given as esomeprazole magnesium trihydrate capsules once daily
Placebo
Overall Number of Participants Analyzed 315 311 326
Least Squares Mean (Standard Error)
Unit of Measure: Inhalations
-0.77  (0.10) -0.73  (0.10) -0.68  (0.10)
5.Secondary Outcome
Title Changes in Average Value From Baseline to Treatment Period in Percentage of Nights With Awakening(s) Due to Asthma
Hide Description Change in percentage of nights with night-time awakening(s) due to asthma from baseline to the end of the study (6 months). Participants must have both baseline and follow up measure to be included in analysis.
Time Frame Baseline to 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Esomeprazole 40 mg Twice Daily Esomeprazole 40 mg Once Daily Placebo
Hide Arm/Group Description:
Nexium 40 mg given as esomeprazole magnesium trihydrate capsules twice daily
Nexium 40 mg given as esomeprazole magnesium trihydrate capsules once daily
Placebo
Overall Number of Participants Analyzed 316 311 327
Least Squares Mean (Standard Error)
Unit of Measure: Percent of nights
-0.238  (0.018) -0.219  (0.018) -0.223  (0.018)
6.Secondary Outcome
Title Change in Forced Expiratory Volume in 1 Second (FEV1) From Randomization to Treatment Period.
Hide Description Description: Changes in forced expiratory volume in 1 second (FEV1) from randomization (Visit 3) to the treatment period considered as mean value at Visits 4-7. Participants must have both baseline and follow up measure to be included in analysis.
Time Frame From randomization (Visit 3) to visit 7.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Esomeprazole 40 mg Twice Daily Esomeprazole 40 mg Once Daily Placebo
Hide Arm/Group Description:
Nexium 40 mg given as esomeprazole magnesium trihydrate capsules twice daily
Nexium 40 mg given as esomeprazole magnesium trihydrate capsules once daily
Placebo
Overall Number of Participants Analyzed 312 306 324
Least Squares Mean (Standard Error)
Unit of Measure: Liters
0.09  (0.02) 0.07  (0.02) 0.02  (0.02)
7.Secondary Outcome
Title Number of Patients With Severe Asthma Exacerbations.
Hide Description [Not Specified]
Time Frame Up to 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Esomeprazole 40 mg Twice Daily Esomeprazole 40 mg Once Daily Placebo
Hide Arm/Group Description:
Nexium 40 mg given as esomeprazole magnesium trihydrate capsules twice daily
Nexium 40 mg given as esomeprazole magnesium trihydrate capsules once daily
Placebo
Overall Number of Participants Analyzed 318 312 327
Measure Type: Number
Unit of Measure: Participants
33 41 43
8.Secondary Outcome
Title Change in Asthma Quality of Life Questionnaire, Standardized Version (AQLQ(S)) Scores From Randomization (Visit 3) to Visit 7
Hide Description The Asthma Quality of Life Questionnaire, Standardized Version (AQLQ(S))has been developed by and includes 32 questions in 4 domains: activity limitation, symptoms, emotional function, and exposure to environmental stimuli. It is used to measure the physical and emotional impact of the disease in the selected areas of life. Participants must have both baseline and follow up measure to be included in analysis.AQLQ(S) score based on a 7-point scale that ranged from 1 (worst quality of life) to 7 (best quality of life).
Time Frame From randomization (Visit 3) to Visit 7
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Esomeprazole 40 mg Twice Daily Esomeprazole 40 mg Once Daily Placebo
Hide Arm/Group Description:
Nexium 40 mg given as esomeprazole magnesium trihydrate capsules twice daily
Nexium 40 mg given as esomeprazole magnesium trihydrate capsules once daily
Placebo
Overall Number of Participants Analyzed 272 275 288
Least Squares Mean (Standard Error)
Unit of Measure: Scores on a scale
0.97  (0.07) 0.83  (0.07) 0.55  (0.07)
9.Secondary Outcome
Title Change in Symptoms of GERD as Measured by Reflux Disease Questionnaire (RDQ) From Randomization (Visit 3) to Visit 7
Hide Description The RDQ questionnaire is used to assess six GI symptoms during the previous week (a burning feeling behind the breastbone, pain behind the breastbone, a burning feeling in the centre of the stomach, pain in the centre of the stomach, an acid taste in the mouth, unpleasant movement of material upwards from the stomach). Each symptom is given a frequency score on a six-point scale (from 0=did not have to 5=daily) and an intensity score on a six-point scale (from 0=did not have to 5=severe). Three domain scores are calculated by forming averages of the frequency and intensity scores of selected symptoms (heartburn: the first two symptoms; dyspepsia: the next two symptoms; regurgitation: the last two symptoms). The overall GERD score is calculated as the average of the hearburn and dyspepsia domain scores. The GERD score can thus range from 0 to 5.
Time Frame Randomization (Visit 3) to Visit 7
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Esomeprazole 40 mg Twice Daily Esomeprazole 40 mg Once Daily Placebo
Hide Arm/Group Description:
Nexium 40 mg given as esomeprazole magnesium trihydrate capsules twice daily
Nexium 40 mg given as esomeprazole magnesium trihydrate capsules once daily
Placebo
Overall Number of Participants Analyzed 316 311 327
Least Squares Mean (Standard Error)
Unit of Measure: Scores on a scale
-1.95  (0.07) -1.91  (0.07) -1.27  (0.07)
10.Secondary Outcome
Title Number of Severe Adverse Events
Hide Description [Not Specified]
Time Frame Up to 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Esomeprazole 40 mg Twice Daily Esomeprazole 40 mg Once Daily Placebo
Hide Arm/Group Description:
Nexium 40 mg given as esomeprazole magnesium trihydrate capsules twice daily
Nexium 40 mg given as esomeprazole magnesium trihydrate capsules once daily
Placebo
Overall Number of Participants Analyzed 316 311 327
Measure Type: Number
Unit of Measure: Events
4 5 9
11.Secondary Outcome
Title Changes in Average Value From Baseline to Treatment Period in Asthma Symptom Score - Night
Hide Description Participants must have both baseline and follow up measure to be included in analysis
Time Frame Baseline to 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Esomeprazole 40 mg Twice Daily Esomeprazole 40 mg Once Daily Placebo
Hide Arm/Group Description:
Nexium 40 mg given as esomeprazole magnesium trihydrate capsules twice daily
Nexium 40 mg given as esomeprazole magnesium trihydrate capsules once daily
Placebo
Overall Number of Participants Analyzed 316 311 327
Least Squares Mean (Standard Error)
Unit of Measure: Scores on a scale
-0.31  (0.03) -0.23  (0.03) -0.27  (0.03)
12.Secondary Outcome
Title Changes in Average Value From Baseline to Treatment Period in Asthma Symptom Score - Day
Hide Description Participants must have both baseline and follow up measure to be included in analysis
Time Frame Baseline to 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Esomeprazole 40 mg Twice Daily Esomeprazole 40 mg Once Daily Placebo
Hide Arm/Group Description:
Nexium 40 mg given as esomeprazole magnesium trihydrate capsules twice daily
Nexium 40 mg given as esomeprazole magnesium trihydrate capsules once daily
Placebo
Overall Number of Participants Analyzed 316 311 327
Least Squares Mean (Standard Error)
Unit of Measure: Scores on a scale
-0.30  (0.03) -0.25  (0.03) -0.25  (0.03)
13.Secondary Outcome
Title Changes in Average Value From Baseline to Treatment Period in Number of Inhalations of Short-acting β2-agonists (SABAs) - Night
Hide Description Participants must have both baseline and follow up measure to be included in analysis
Time Frame Baseline to 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Esomeprazole 40 mg Twice Daily Esomeprazole 40 mg Once Daily Placebo
Hide Arm/Group Description:
Nexium 40 mg given as esomeprazole magnesium trihydrate capsules twice daily
Nexium 40 mg given as esomeprazole magnesium trihydrate capsules once daily
Placebo
Overall Number of Participants Analyzed 316 311 327
Least Squares Mean (Standard Error)
Unit of Measure: Inhalations
-0.30  (0.05) -0.27  (0.05) -0.29  (0.04)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Esomeprazole 40 mg Twice Daily Esomeprazole 40 mg Once Daily Placebo
Hide Arm/Group Description Nexium 40 mg given as esomeprazole magnesium trihydrate capsules twice daily Nexium 40 mg given as esomeprazole magnesium trihydrate capsules once daily Placebo
All-Cause Mortality
Esomeprazole 40 mg Twice Daily Esomeprazole 40 mg Once Daily Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Esomeprazole 40 mg Twice Daily Esomeprazole 40 mg Once Daily Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   7/319 (2.19%)   5/313 (1.60%)   5/328 (1.52%) 
Gastrointestinal disorders       
Abdominal Pain * 1  0/319 (0.00%)  0/313 (0.00%)  1/328 (0.30%) 
Umbilical Hernia * 1  0/319 (0.00%)  1/313 (0.32%)  0/328 (0.00%) 
Hepatobiliary disorders       
Cholecystitis Acute * 1  0/319 (0.00%)  1/313 (0.32%)  0/328 (0.00%) 
Cholecystitis Chronic * 1  1/319 (0.31%)  0/313 (0.00%)  0/328 (0.00%) 
Infections and infestations       
Chronic Sinusitis * 1  0/319 (0.00%)  0/313 (0.00%)  1/328 (0.30%) 
Salmonellosis * 1  1/319 (0.31%)  0/313 (0.00%)  0/328 (0.00%) 
Tuberculosis * 1  1/319 (0.31%)  0/313 (0.00%)  0/328 (0.00%) 
Injury, poisoning and procedural complications       
Contusion * 1  0/319 (0.00%)  0/313 (0.00%)  1/328 (0.30%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Small Intestine Carcinoma * 1  1/319 (0.31%)  0/313 (0.00%)  0/328 (0.00%) 
Nervous system disorders       
Migraine With Aura * 1  0/319 (0.00%)  1/313 (0.32%)  0/328 (0.00%) 
Renal and urinary disorders       
Nephrolithiasis * 1  1/319 (0.31%)  0/313 (0.00%)  1/328 (0.30%) 
Renal Colic * 1  1/319 (0.31%)  0/313 (0.00%)  0/328 (0.00%) 
Reproductive system and breast disorders       
Cervical Dysplasia * 1  1/319 (0.31%)  0/313 (0.00%)  0/328 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Asthma * 1  1/319 (0.31%)  0/313 (0.00%)  1/328 (0.30%) 
Pulmonary Embolism * 1  0/319 (0.00%)  1/313 (0.32%)  0/328 (0.00%) 
Sinus Polyp * 1  0/319 (0.00%)  0/313 (0.00%)  1/328 (0.30%) 
Vascular disorders       
Hypertension  1  1/319 (0.31%)  1/313 (0.32%)  0/328 (0.00%) 
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 10.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Esomeprazole 40 mg Twice Daily Esomeprazole 40 mg Once Daily Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   37/319 (11.60%)   44/313 (14.06%)   55/328 (16.77%) 
Infections and infestations       
Bronchitis * 1  11/319 (3.45%)  16/313 (5.11%)  18/328 (5.49%) 
Upper Respiratory Tract Infection * 1  26/319 (8.15%)  28/313 (8.95%)  37/328 (11.28%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 10.0
Numbers of patients analyzed in each of the Outcome Measures varies due to the amount of qualifying data captured for the patients.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: ClinicalTrialTransparency
Organization: AstraZeneca
EMail: ClinicalTrialTransparency@astrazeneca.com
Layout table for additonal information
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00317044     History of Changes
Other Study ID Numbers: D9618C00001
RELAX
First Submitted: April 20, 2006
First Posted: April 24, 2006
Results First Submitted: April 23, 2009
Results First Posted: June 9, 2014
Last Update Posted: June 9, 2014